title: Genistein in the metabolic syndrome: results of a randomized clinical trial.
abstract: BACKGROUND
  This study was performed to evaluate the effects of genistein on metabolic and cardiovascular risk factors in Caucasian postmenopausal subjects with metabolic syndrome (MetS).
  
  
  OBJECTIVE
  Our objective was to assess the effects of genistein on surrogate endpoints associated with diabetes and cardiovascular disease.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled trial at 3 university medical centers in Italy.
  
  
  METHODS
  Patients included 120 postmenopausal women with MetS according to modified Third Report of the National Cholesterol Education Program (NCEP), Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) criteria.
  
  
  METHODS
  After a 4-week stabilization period, postmenopausal women with MetS were randomly assigned to receive placebo (n = 60) or 54 mg genistein daily (n = 60) for 1 year.
  
  
  METHODS
  The primary outcome was homeostasis model assessment for insulin resistance (HOMA-IR) at 1 year. Secondary outcomes were fasting glucose, fasting insulin, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, visfatin, adiponectin, and homocysteine levels. Data on adverse events were also recorded.
  
  
  RESULTS
  At 1 year in genistein recipients, fasting glucose, fasting insulin, and HOMA-IR (mean from 4.5 to 2.7; P < .001) decreased and were unchanged in placebo recipients. Genistein statistically increased HDL-C (mean from 46.4 to 56.8 mg/dL) and adiponectin and decreased total cholesterol, LDL-C (mean from 108.8 to 78.7 mg/dL), triglycerides, visfatin, and homocysteine (mean from 14.3 to 11.7 μmol/L) blood levels. Systolic and diastolic blood pressure was also reduced in genistein recipients. Genistein recipients neither experienced more side adverse effects than placebo nor discontinued the study.
  
  
  CONCLUSIONS
  One year of treatment with genistein improves surrogate endpoints associated with risk for diabetes and cardiovascular disease in postmenopausal women with MetS.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy. Francesco.Squadrito@unime.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Squadrito
authors.forename: Herbert
authors.initials: H
authors.lastname: Marini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bitto
authors.forename: Domenica
authors.initials: D
authors.lastname: Altavilla
authors.forename: Francesca
authors.initials: F
authors.lastname: Polito
authors.forename: Elena Bianca
authors.initials: EB
authors.lastname: Adamo
authors.forename: Rosario
authors.initials: R
authors.lastname: D'Anna
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Arcoraci
authors.forename: Bruce P
authors.initials: BP
authors.lastname: Burnett
authors.forename: Letteria
authors.initials: L
authors.lastname: Minutoli
authors.forename: Antonino
authors.initials: A
authors.lastname: Di Benedetto
authors.forename: Giacoma
authors.initials: G
authors.lastname: Di Vieste
authors.forename: Domenico
authors.initials: D
authors.lastname: Cucinotta
authors.forename: Cesare
authors.initials: C
authors.lastname: de Gregorio
authors.forename: Silvia
authors.initials: S
authors.lastname: Russo
authors.forename: Francesco
authors.initials: F
authors.lastname: Corrado
authors.forename: Antonino
authors.initials: A
authors.lastname: Saitta
authors.forename: Concetta
authors.initials: C
authors.lastname: Irace
authors.forename: Salvatore
authors.initials: S
authors.lastname: Corrao
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Licata
mesh_terms: D000368:Aged; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D019833:Genistein / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007333:Insulin Resistance; D024821:Metabolic Syndrome / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D019833:Genistein